Rx Item-Cervarix 20 20 0.5 Syringe 10X0.5ml By Glaxo Smith Kline Vaccines

CERVARIX- human papillomavirus type 16 l1 capsid protein residues 2-471 antigen and human papillomavirus type 18 l1 capsid protein residues 2-472 antigen injection, suspension
GlaxoSmithKline Biologicals SA

1 INDICATIONS AND USAGE

1.1 Indications
CERVARIX� is indicated for the prevention of the following diseases caused by oncogenic human papillomavirus (HPV) types 16 and 18 [see Clinical Studies (14)]:

�
cervical cancer,
�
cervical intraepithelial neoplasia (CIN) Grade 2 or worse and adenocarcinoma in situ , and
�
cervical intraepithelial neoplasia (CIN) Grade 1.


CERVARIX is approved for use in females 9 through 25 years of age.

1.2 Limitations of Use and Effectiveness
CERVARIX does not provide protection against disease due to all HPV types [see Clinical Studies (14.3)].

CERVARIX has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity [see Clinical Studies (14.2)].

Females should continue to adhere to recommended cervical cancer screening procedures [see Patient Counseling Information (17)].

Vaccination with CERVARIX may not result in protection in all vaccine recipients.

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration
Shake syringe well before withdrawal and use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered. With thorough agitation, CERVARIX is a homogeneous, turbid, white suspension. Do not administer if it appears otherwise.

Attach a sterile needle and administer intramuscularly.

Do not administer this product intravenously, intradermally, or subcutaneously.

2.2 Dose and Schedule
Immunization with CERVARIX consists of 3 doses of 0.5-mL each, by intramuscular injection according to the following schedule: 0, 1, and 6 months. The preferred site of administration is the deltoid region of the upper arm.

3 DOSAGE FORMS AND STRENGTHS

CERVARIX is a suspension for intramuscular injection available in 0.5-mL single-dose prefilled TIP-LOK� syringes.

Rx Item-Cervarix 20 20 0.5 Syringe 10X0.
Item No.: RX182283 NDC No.58160083052 UPC No.:358160830525 NDC No. 58160-0830-52 UPC/GTIN No. 3-58160-83052-5 MPN No. 83052 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.

Cervarix 20 20 0.5 Syringe 10X0.5Ml By G
BRAND: CERVARIX NDC: 58160-0830-52,58160083052 UPC: 3-58160-83052-5,358160830525 Glaxo Smith Kline /Vaccines

HUMAN PAPILLOMAV VACC BIV
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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